Glycosylation characterization of protein-based biologics is certainly one of the most important critical quality attributes (CQA) during the manufacturing of biologics, as even simple changes in the up- and downstream process can have a significant impact on the glycol profile of your target protein. Especially the glycosylation patterns of the FC and FAB regions of monoclonal antibodies can have a crucial impact on the efficacy and safety of the biopharmaceutical compound. Therefore, a detailed characterization of these post-translational modifications is a mandatory requirement of regulatory authorities such as the FDA and EMA. To guarantee a targeted development of biosimilars and novel biopharmaceuticals, comparison of the N-glycosylation profile of your product to a clinical-grade reference drug is of fundamental importance to make an early decision on the cell line used for further developments. To avoid a serious loss of time and budget, a tailored characterization of the glycosylation heterogeneity of different batches and reference samples should be carried out at the beginning of any biosimilar development.
Our scientists at Biofidus AG know how to routinely and reliably determine O- and N-linked glycosylations and help you define appropriate acceptance criteria for your product development.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your API, its individual formulation matrix and your distinct analytical question.
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